The DSMP is made available to all MCCC investigators through the MCCC intranet. The plan addresses: ? Monitoring the progress of trials and safety of participants ? Plans for assuring compliance with requirements regarding reporting of adverse events ? Plans for assuring action resulting in temporary or permanent suspension of an NCI-funded clinical trial ? Plans for assuring data accuracy and protocol compliance The plan covers all trials. Approval of the DSMP was received in 2012 by both the NCI and the Mayo IRB. It is reviewed and updated on an annual basis, or more often as needed by the DSMC.